An Open-Label Study to Assess the Safety and Efficacy of Remdesivir for Treatment of Symptomatic Laboratory-Confirmed Respiratory Syncytial Virus Infection of the Upper Respiratory Tract in Patients Receiving Cellular or Bispecific Antibody Therapies
Summary
This phase II trial tests how well remdesivir works for treatment of respiratory syncytial virus (RSV) infection of the upper respiratory tract in patients receiving cellular or bispecific antibody therapy. Cellular or bispecific antibody therapies cause suppression of the immune system, making infections more frequent and reducing the body's ability to fight the infections. RSV infections are one of the most common respiratory infections in immunocompromised individuals and can cause significant pneumonia and even death. Remdesivir is in a class of medications called antivirals. It works by stopping viruses from spreading in the body.
Detailed description
OUTLINE: Patients receive remdesivir intravenously (IV) over 30-120 minutes on days 1-5, with the option to extend to day 10 at the investigator's discretion, in the absence of disease progression or unacceptable toxicity. Patients also undergo nasal swabs and blood sample collection throughout the study. After completion of study treatment, patients are followed up on day 14 and 29.
Arms & interventions
- DrugRemdesivir
Given IV
- OtherSurvey Administration
Ancillary studies
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureNasal Swab
Undergo nasal swabs
Outcome measures
Primary
Proportion of participants requiring ≥ 2 liters/minute of oxygen for ≥ 24 consecutive hours
Will be estimated with 95% Wilson confidence intervals.
Time frame: Up to day 29
Secondary
Incidence of treatment-emergent adverse events (AEs) and laboratory abnormalities
Time frame: Up to day 29
Incidence of serious adverse events and AEs leading to study drug discontinuation
Time frame: Up to day 29
Proportion of participants with RSV-related hospitalization (if not hospitalized at the time of first dose) or death
Time frame: Up to day 29
Supplemental oxygen free days
Time frame: Up to day 29
Proportion of participants who develop new or worsening pulmonary infiltrates
Time frame: Up to day 29
Proportion of participants requiring high-flow nasal cannula, non-invasive ventilation, or invasive mechanical ventilation for ≥ 24 consecutive hours
Time frame: Up to day 29
Proportion of participants admitted to intensive care unit
Time frame: Up to day 29
Proportion of participants who die
Time frame: Up to day 29
Change from baseline in RSV nasal swab viral load
Time frame: From baseline through day 3 and 5
Maximum daily Respiratory Infection Intensity and Impact Questionnaire (RiiQ) score
Time frame: From baseline to day 29
Eligibility criteria
Study locations (3)
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
MD Anderson Cancer Center
Houston, Texas, 77030
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109